Chemotherapy +/− Ramucirumab for Thymic Cancer

No longer recruiting at 253 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SWOG Cancer Research Network

Must not be taking: Antiplatelets, NSAIDs

Disqualifiers: Hypertension, Thromboembolism, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a chemotherapy combination for treating thymic cancer that cannot be surgically removed, has returned, or has spread. Participants will receive standard chemotherapy with carboplatin and paclitaxel, while some will also receive ramucirumab, a targeted therapy designed to potentially inhibit cancer growth. The trial aims to determine if adding ramucirumab improves treatment outcomes. It may be suitable for those with advanced thymic cancer who cannot undergo surgery and have not previously received chemotherapy for this cancer type. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on warfarin, you must switch to low molecular weight heparin 14 days before joining the trial. Also, you should not be on chronic antiplatelet therapy, like certain NSAIDs, within 7 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the combination of ramucirumab with carboplatin and paclitaxel was generally well-tolerated. Most patients did not experience severe side effects, though some reported mild to moderate ones, such as tiredness, nausea, or low blood cell counts. These effects are common with many cancer treatments.

Carboplatin and paclitaxel have been used together in cancer care for a long time. They are known to cause side effects like hair loss, nerve pain, and low blood cell counts, but these are expected and manageable.

Overall, the treatments in this trial have demonstrated a safety profile suggesting they are generally safe to use, with side effects that are usually manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of ramucirumab with carboplatin and paclitaxel for thymic cancer because it introduces a new approach to blocking blood supply to tumors. Unlike other treatments that focus solely on killing cancer cells, ramucirumab works by inhibiting the VEGF receptor, which is crucial for blood vessel growth that tumors need to survive. This mechanism can potentially enhance the effectiveness of chemotherapy drugs like carboplatin and paclitaxel. By targeting the tumor’s blood supply, this combination could offer a more comprehensive attack on cancer cells, potentially improving outcomes for patients with thymic cancer.

What evidence suggests that this trial's treatments could be effective for thymic cancer?

In this trial, participants will receive either a combination of ramucirumab, carboplatin, and paclitaxel, or just carboplatin and paclitaxel. Research has shown that combining ramucirumab with carboplatin and paclitaxel may effectively treat thymic cancer. One study found that 80% of patients experienced a reduction in cancer size, and all patients had their cancer growth controlled. On average, patients went 18.1 months without their cancer worsening. This indicates that many patients saw their cancer shrink or stop growing for a significant time. Carboplatin and paclitaxel are already used together to treat various cancers by stopping tumor growth. While research is ongoing, these findings suggest that adding ramucirumab could enhance the effectiveness of this chemotherapy combination for thymic cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Anne S Tsao

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adults with advanced, recurrent, or metastatic thymic cancer that can't be surgically removed. They should not have had previous systemic anti-cancer therapy for this condition and must have measurable disease. Participants need proper liver and kidney function, no significant blood clots or bleeding in recent months, controlled blood pressure, and cannot be pregnant or breastfeeding.

Inclusion Criteria

My thymic carcinoma cannot be removed by surgery and has spread.

I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

My cancer can be seen on scans taken within the last 28 days.

Exclusion Criteria

I do not have any disqualifying conditions.

My liver disease is severe (Child-Pugh B or worse).

I have liver cirrhosis and a history of brain issues due to it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive carboplatin and paclitaxel with or without ramucirumab every 21 days for up to 6 cycles

18 weeks

6 visits (in-person)

Extension

Patients who have not progressed may continue to receive ramucirumab for up to 1 year

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months for 1 year, then every 6 months for 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Paclitaxel
• Ramucirumab

Trial Overview The study compares the effectiveness of chemotherapy drugs carboplatin and paclitaxel alone versus combined with ramucirumab (a monoclonal antibody) in treating thymic cancer. The goal is to see if adding ramucirumab improves treatment outcomes compared to just chemotherapy.

How Is the Trial Designed?

Group I: Arm A (ramucirumab, carboplatin, paclitaxel) Experimental Treatment 3 Interventions

Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.

Group II: Arm B (carboplatin, paclitaxel) Active Control 2 Interventions

Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A multicenter phase II study is investigating the combination of atezolizumab (an anti-PD-L1 antibody) with carboplatin and paclitaxel in 47 patients with advanced or recurrent thymic carcinoma, aiming to improve treatment outcomes compared to standard chemotherapy.

The study will assess the safety and efficacy of this combination therapy, with the primary focus on the objective response rate, and will follow patients for up to 2 years to evaluate long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Design and Rationale for Marble Study: A Phase II Trial of Atezolizumab (MPDL3280A) Plus Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Thymic Carcinoma (JTD2101). Asao, T., Shukuya, T., Mimori, T., et al.[2023]

In three cases of unresectable and locally advanced thymic carcinoma resistant to cisplatin, treatment with carboplatin and paclitaxel as salvage chemotherapy resulted in two patients showing a partial response and one showing a minor response.

The findings suggest that thymic carcinoma is sensitive to platinum-based chemotherapy, and paclitaxel may also be an effective treatment option for this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvage chemotherapy with carboplatin and paclitaxel for cisplatin-resistant thymic carcinoma--three cases. Komatsu, Y., Koizumi, T., Tanabe, T., et al.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38857846/

Efficacy and safety of ramucirumab plus carboplatin and ... The RELEVENT trial was designed to evaluate the activity and safety of ramucirumab plus chemotherapy as first-line treatment in advanced TC.

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)00724-5/fulltext

Efficacy and safety of ramucirumab plus carboplatin and ... Ramucirumab, carboplatin and paclitaxel combination shows ORR of 80%, disease control rate of 100%, and median PFS of 18.1 months in untreated ...

3. jtocrr.org jtocrr.org/article/S2666-3643(24)00108-5/fulltext

S1701, A Randomized Phase 2 Trial of Carboplatin ... This single-arm phase 2 trial of 32 patients with thymoma/thymic carcinomas (27 patients had thymic carcinoma) had an ORR of 34% with the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03921671

Study Details | NCT03921671 | Ramucirumab and Carbo ... This is a multicentric study. All patients with TET (thymic epithelial tumors) of any histological type will participate in the study.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0169500225004465

Therapeutic management of patients with advanced thymic ... The overall response rate (ORR) is around 70–80 %, and in patients for whom R0 resection is considered feasible, complete resection is achieved in approximately ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12328473/

Therapeutic Management of Metastatic Thymoma and ... The expected response rates are approximately 40% for thymoma and 20% for thymic carcinoma [6, 29, 30, 31, 32, 33]. Table 1. Preferred ...